FDA Classifies AVID Medical Huons Sodium Chloride Kit Correction as Class I
FDA has classified the recall of specified AVID Medical convenience kits containing recalled Huons sodium chloride flush ampules as Class I because of product quality and sterility-assurance concerns affecting the saline components.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
AVID Medical is correcting specified convenience kits that contain Sodium Chloride Injection 0.9%, USP 10 mL flush ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices because of product quality and sterility-assurance concerns. The correction does not require removal of the entire convenience kit from where it is used or sold. FDA classified the action as a Class I recall on September 21, 2026.
MedTech Current analysis
Why it matters
Use of affected sodium chloride ampules may expose patients to viable microorganisms, endotoxins, or foreign matter, potentially causing inflammatory responses and infections. The FDA notes particular concern when treatment occurs near highly injury-sensitive structures such as the spinal cord, where contamination may contribute to abscess formation and subsequent paralysis. As of August 10, AVID Medical had reported no serious injuries and no deaths associated with the issue.
Actions by role
MedTech Current analysis — editorial interpretation, not FDA-authored guidance.
- MedTech Current analysisManufacturers and suppliersverify component qualification, sterility-assurance, kit-level traceability, and downstream notification controls when a recalled drug or saline component is incorporated into a convenience kit.
- MedTech Current analysisHealthcare facilities and professionalsidentify affected kit lots, quarantine them, remove and discard the affected ampules before use, and document the response.
- MedTech Current analysisGeneral MedTech readersdistinguish the official FDA correction instructions from the broader operational implications of component-level recalls.
Official recall information
Official actions
According to AVID Medical's August 10 customer communication and FDA's recall database instructions:
- Identify, segregate, and quarantine affected kits; apply the supplied warning label to affected kits and cases without covering other critical labeling.
- Remove and discard the Sodium Chloride Injection 0.9%, USP 10 mL flush ampules before using the kit; the remaining kit components may continue to be used after the affected ampule is removed.
- Complete and return the Recall Response Form, and distributors should notify end users if affected kits were further distributed and maintain downstream-notification records.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
AVID Medical is correcting specified convenience kits that contain Sodium Chloride Injection 0.9%, USP 10 mL flush ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices because of product quality and sterility-assurance concerns. The correction does not require removal of the entire convenience kit from where it is used or sold. FDA classified the action as a Class I recall on September 21, 2026.
The FDA first issued an Early Alert on September 2. According to the FDA communication, use of affected sodium chloride ampules may expose patients to viable microorganisms, endotoxins, or foreign matter, potentially causing inflammatory responses and infections. The FDA notes particular concern when treatment occurs near highly injury-sensitive structures such as the spinal cord, where contamination may contribute to abscess formation and subsequent paralysis.
As of August 10, AVID Medical had reported no serious injuries and no deaths associated with the issue.
Who and what are affected
The recall covers four AVID Medical convenience-kit configurations under FDA Recall Event ID 99758:
| Product | Model / item number | UDI-DI | FDA recall number |
|---|---|---|---|
| 18G SINGLE SHOT EPI TRAY | DPGE002-02 | 10809160410325 | Z-3151-2026 |
| CONTINUOUS NERVE BLOCK TRAY | BMCN001-05 | 10809160455128 | Z-3152-2026 |
| BASIC BIOPSY TRAY | PM415 | 10809160322154 | Z-3153-2026 |
| UNIV IMAGING BIOPSY TRUCUSTOM | VARV042-03 | 10809160490822 | Z-3154-2026 |
Only specified kit lots are affected. The complete lot list is available through the primary FDA notice and the corresponding FDA recall database records.
What affected organizations should do
Affected customers
According to AVID Medical’s August 10 customer communication:
- Identify, segregate, and quarantine affected kits.
- Apply the supplied warning label to affected kits and cases in a prominently visible location that does not cover other critical labeling.
- Remove and discard the Sodium Chloride Injection 0.9%, USP 10 mL flush ampules before using the kit.
- Continue using the remaining kit components after the affected sodium chloride ampule has been removed.
- Complete and return the Recall Response Form.
Distributors
According to the FDA recall database:
- Notify end users if affected kits were further distributed.
- Maintain records showing that downstream notification was completed.